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Hanaulux Blue 75 and Hanaulux Blue 120

by Heraeus Med GmbH

510(k) K973466

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973466 Date24 Oct 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FSY
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a surgical ceiling-mounted light, as defined by its device type and nomenclature. It is designed to provide illumination during surgical procedures.

The HANAULUX BLUE 75 and HANAULUX BLUE 120 are supplied as reusable devices intended for use in general and plastic surgery settings. They received FDA 510(k) clearance (K973466) on October 24, 1997, and are classified as Class II medical devices under regulation number 878.4580.

Other devices from Heraeus Med GmbH

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HANAULUX BLUE 75 and 120 used for?

    The HANAULUX BLUE 75 and HANAULUX BLUE 120 are surgical ceiling-mounted lights designed to provide illumination during surgical procedures in general and plastic surgery settings, as specified in the device description and advisory committee classification.

  • Is the HANAULUX BLUE 75 and 120 reusable or single-use?

    The device is supplied as a reusable device, meaning it is intended for multiple uses after proper cleaning and sterilization between procedures, as stated in the description under intended use and supply information.

  • What regulatory clearance does the HANAULUX BLUE 75 and 120 have?

    The HANAULUX BLUE 75 and HANAULUX BLUE 120 received FDA 510(k) clearance under submission number K973466 on October 24, 1997, and are classified as Class II medical devices under regulation number 878.4580, as documented in the authorizations and specifications sections.